Back to resultsA Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions
Primary Purpose
Breast Tumors
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SonoVue (sulphur hexafluoride microbubbles)
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Tumors focused on measuring Contrast-enhanced Ultrasound Sonography, Ultrasound Contrast agents, microbubbles, Breast tumors
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Woman presenting with: enlarging fibroadenoma (less than 2 cm in diameter or woman over 40 years old with fibroadenoma less than 2 cm in diameter) or suspect malignant nodule (less than 2 cm in diameter) or a cluster of microcalcification or a malignant nodule (size greater than 3 cm) diagnosed with mammography and/or MRI and/or United States (US) examination performed within 1 month before the study. Woman scheduled for biopsy or surgery within 1 month from the examination. Exclusion Criteria: Patients who have already performed a biopsy on the lesion during investigation Any contraindication to perform a contrast-enhanced MRI examination for the patients presenting with a malignant nodule (size greater than 3 cm) Patients previously entered in this study or having received an investigational drug within 30 days prior to admission to this study Patients with any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data or of achieving the study objectives (drug dependence, psychiatric disorders, dementia or other reasons) Pregnant or nursing female Patient known to have a coronary syndrome Unstable angina and myocardial infarction Acute cardiac failure, Class III/IV cardiac failure Severe rhythm disorders Acute endocarditis Prosthetic valves
Sites / Locations
- University Hospital of Tours
Outcomes
Primary Outcome Measures
From contrast-enhanced ultrasound: Time-intensity curves obtained with SonoVue will help the investigators in differentiation of lesions based on different enhancements.
Secondary Outcome Measures
Histology assessments: Microvessel density assessments to evaluate the total amount of microcirculation and the neoangiogenesis microcirculation present in the samples
Off-line time-intensity curves from contrast-enhanced magnetic resonance imaging (MRI) images (malignant nodule greater than 3 cm in diameter only)
Full Information
NCT ID
NCT00243698
First Posted
October 21, 2005
Last Updated
November 21, 2007
Sponsor
University Hospital, Tours
1. Study Identification
Unique Protocol Identification Number
NCT00243698
Brief Title
A Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions
Official Title
A Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Tours
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Ultrasound is a well-established imaging modality for the evaluation of breast disease.
The investigators' objective is to characterise the properties of an intravascular ultrasonographic contrast agent SonoVue (sulphur hexafluoride microbubbles) to improve the diagnostic value of the ultrasound examination in patients with different breast lesions.
The final purpose of this ultrasonography is to allow the early detection of tumors and to improve the differentiation between benign and malignant lesions.
SonoVue® (sulphur hexafluoride microbubbles) is a microbubbles preparation that is stable, resistant to pressure, and specifically designed to be used as a contrast agent for ultrasound imaging.
Contrast-enhanced ultrasound could provide a non-invasive technique to evaluate the morphology of breast tumour vascularity.
Detailed Description
The main objective of the study is to evaluate the efficacy of SonoVue® to detect breast lesions and define specific microcirculation patterns in patients with four different type of breast lesions (enlarging fibroadenoma, suspect malignant nodules, microcalcification and large malignant nodules) in comparison with pathological specimens in terms of histology diagnosis and microvessel density evaluation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Tumors
Keywords
Contrast-enhanced Ultrasound Sonography, Ultrasound Contrast agents, microbubbles, Breast tumors
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SonoVue (sulphur hexafluoride microbubbles)
Intervention Description
One contrast enhanced ultrasonography using sonovue / 4.8 ml per injection (maximum of 3 injections)
Primary Outcome Measure Information:
Title
From contrast-enhanced ultrasound: Time-intensity curves obtained with SonoVue will help the investigators in differentiation of lesions based on different enhancements.
Time Frame
Inclusion period
Secondary Outcome Measure Information:
Title
Histology assessments: Microvessel density assessments to evaluate the total amount of microcirculation and the neoangiogenesis microcirculation present in the samples
Time Frame
inclusion period
Title
Off-line time-intensity curves from contrast-enhanced magnetic resonance imaging (MRI) images (malignant nodule greater than 3 cm in diameter only)
Time Frame
inclusion period
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
Woman presenting with: enlarging fibroadenoma (less than 2 cm in diameter or woman over 40 years old with fibroadenoma less than 2 cm in diameter) or suspect malignant nodule (less than 2 cm in diameter) or a cluster of microcalcification or a malignant nodule (size greater than 3 cm) diagnosed with mammography and/or MRI and/or United States (US) examination performed within 1 month before the study.
Woman scheduled for biopsy or surgery within 1 month from the examination.
Exclusion Criteria:
Patients who have already performed a biopsy on the lesion during investigation
Any contraindication to perform a contrast-enhanced MRI examination for the patients presenting with a malignant nodule (size greater than 3 cm)
Patients previously entered in this study or having received an investigational drug within 30 days prior to admission to this study
Patients with any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data or of achieving the study objectives (drug dependence, psychiatric disorders, dementia or other reasons)
Pregnant or nursing female
Patient known to have a coronary syndrome
Unstable angina and myocardial infarction
Acute cardiac failure, Class III/IV cardiac failure
Severe rhythm disorders
Acute endocarditis
Prosthetic valves
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Tranquart, PR
Organizational Affiliation
Centre d'Innovation Technologique CHRU Tours
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Catherine LABBE, MD
Organizational Affiliation
CRLCC René Gauducheau 44805 ST HERBLAIN
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Tours
City
Tours
ZIP/Postal Code
37044
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
15664287
Citation
Kettenbach J, Helbich TH, Huber S, Zuna I, Dock W. Computer-assisted quantitative assessment of power Doppler US: effects of microbubble contrast agent in the differentiation of breast tumors. Eur J Radiol. 2005 Feb;53(2):238-44. doi: 10.1016/j.ejrad.2004.04.017.
Results Reference
background
PubMed Identifier
15657523
Citation
Singh S, Pradhan S, Shukla RC, Ansari MA, Kumar A. Color Doppler ultrasound as an objective assessment tool for chemotherapeutic response in advanced breast cancer. Breast Cancer. 2005;12(1):45-51. doi: 10.2325/jbcs.12.45.
Results Reference
background
PubMed Identifier
15010893
Citation
Watermann D, Madjar H, Sauerbrei W, Hirt V, Prompeler H, Stickeler E. Assessment of breast cancer vascularisation by Doppler ultrasound as a prognostic factor of survival. Oncol Rep. 2004 Apr;11(4):905-10.
Results Reference
background
PubMed Identifier
14658595
Citation
Martinez AM, Medina CJ, Bustos C, Hernandez JA. Assessment of breast lesions using Doppler with contrast agents. Eur J Gynaecol Oncol. 2003;24(6):527-30.
Results Reference
background
PubMed Identifier
8372225
Citation
Cosgrove DO, Kedar RP, Bamber JC, al-Murrani B, Davey JB, Fisher C, McKinna JA, Svensson WE, Tohno E, Vagios E, et al. Breast diseases: color Doppler US in differential diagnosis. Radiology. 1993 Oct;189(1):99-104. doi: 10.1148/radiology.189.1.8372225.
Results Reference
result
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A Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions
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